May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

The purpose of this Funding Opportunity Announcement (FOA)
is to stimulate research to evaluate the effect of care planning on cancer survivors'
health and psychosocial outcomes; self-management of late effects and
adherence to cancer screening and health behavior guidelines; utilization of
follow-up care; organizational-level factors influencing the implementation
of care planning; and associated costs. Specifically, the FOA aims to
stimulate research that will: 1) develop and test metrics for evaluating the
impact of survivorship care planning; 2) evaluate the impact of survivorship
care planning on cancer survivors' morbidity, self-management and adherence
to care recommendations, utilization of follow-up care, and on systems
outcomes, such as associated costs and impact on organizations implementing
care planning; and 3) identify models and processes of care that promote
effective survivorship care planning. The ultimate goal of this FOA is to
generate a body of science that will inform the development and delivery of
interventions and best practices in follow-up care for cancer survivors.

Key Dates

Posted Date

August 29, 2012

Open Date (Earliest Submission Date)

January 5, 2013

Letter of Intent Due Date

Not Applicable.

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide, except where instructed to do otherwise
(in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the
Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The purpose of this Funding Opportunity Announcement (FOA)
is to stimulate research to evaluate the effect of care planning on cancer
survivors' health and psychosocial outcomes; self-management of late effects
and adherence to cancer screening and health behavior guidelines; utilization
of follow-up care; organizational-level factors influencing the implementation
of care planning; and associated costs. Specifically, the FOA aims to stimulate
research that will: 1) develop and test metrics for evaluating the impact of
survivorship care planning; 2) evaluate the impact of survivorship care
planning on cancer survivors' morbidity, self-management and adherence to care
recommendations, utilization of follow-up care, and on systems outcomes, such
as associated costs and impact on organizations implementing care planning; and
3) identify models and processes of care that promote effective survivorship
care planning. The ultimate goal of this FOA is to generate a body of science
that will inform the development and delivery of interventions and best
practices in follow-up care for cancer survivors.

This FOA will utilize the Research Project Grant (R01)
mechanism, and runs in parallel with an FOA [PA-12-274],
which uses the Exploratory/Developmental Grant (R21) mechanism.

Background

Cancer
Survivorship

The number of cancer survivors in the United States is
currently estimated at over 12 million and is expected to increase
significantly with the aging of the United States population. Cancer survivors
may experience a host of long-term and late effects that require coordinated
follow-up care after completion of primary treatment for cancer. Researchers
and health care delivery systems have expressed the need to understand how best
to structure and deliver survivorship care that affects these late effects and
how to pay for such care.

Follow-up
Care and Care Planning for Cancer Survivors

The Institute of Medicine (IOM, 2005) recommended that all
patients completing primary cancer treatment be provided with a comprehensive
treatment summary and a survivorship care plan, to be reviewed with the patient
during an end-of-treatment consultation. The treatment summary, care plan, and
consultative visit are intended to improve care coordination and patient
knowledge about the late and long-term effects of cancer, and recommended
follow-up care. The Institute of Medicine Report also called for health
services research to assess the impact, cost, and acceptability of survivorship
care plans to patients and providers. Subsequently, the American Society of
Clinical Oncology and the American College of Surgeons Commission on Cancer
recommended provision of treatment summaries and care plans as a standard of
quality oncology practice. However, the impact of treatment summaries and care
plans on morbidity, utilization, cost, and systems outcomes is not yet known,
and evidence is limited regarding which delivery and coordination strategies
are likely to be feasible, scalable, cost-effective, readily adoptable,
consistently implemented, and sustainable. If treatment summaries and care
plans are to become a standard of care, it is critical that their efficacy and
viability in real world settings be evaluated.

Key
Meetings on Cancer Survivorship Care Planning

The Institute of
Medicine hosted a workshop on survivorship care planning in 2006, in which it
addressed the need for the evaluation and implementation of care planning. The
NCI’s Office of Cancer Survivorship subsequently led a March 2011 workshop on care
planning that revealed a need to rigorously evaluate the impact of survivorship
care planning and to focus on exploring the efficacy of care planning, the
costs and effects of care planning in the context of new care delivery models, and
the feasibility and viability of implementation. The importance of follow-up
care planning in survivorship was reinforced by the September 2011 LiveSTRONG
Essential Elements meeting, in which 125 thought leaders and stakeholders used
the Institute of Medicine recommendations to develop consensus regarding the
essential elements in survivorship care. Provision of a treatment summary/care
plan, and a care coordination strategy for cancer survivors appeared in the top
tier of consensus elements.

Preliminary
Evidence on the Impact of Survivorship Care Planning

Preliminary research suggests
survivorship care planning may be related to improved compliance with
recommended medical surveillance, reductions in duplicative health care
procedures, and improvements in patient confidence about and preparedness for
follow-up care. However, it is unclear whether survivorship care planning
demonstrates added benefit when compared to usual care. Implementation
challenges in care planning include low concordance of observed care plan
content with IOM content recommendations, time burden and lack of reimbursement
for treatment summaries/care plans, lack of clarity regarding who is
responsible for generating and communicating the care plan to patients and
providers, and lack of cost-effectiveness data. The IOM report has been the
basis for the most developed research in care planning. The IOM-recommended
content for survivorship care plans includes the following elements: patient’s
cancer specific information (e.g., diagnosis, stage, pathology, etc.),
treatment history and potential consequences; recommendations for surveillance,
prevention and health maintenance; information about psychosocial sequelae, and
community resources to address psychosocial issues; and detailed plans for
follow-up care and coordination.

The scant research literature, in conjunction with the IOM’s
goals and recommended content for care plans, suggest a research agenda focused
on assessment of whether and how care planning is implemented; evaluation of
concordance of care plan content with IOM recommended elements; effects of care
planning on physical and psychosocial morbidity, surveillance and management of
chronic and late effects of cancer, health care resource utilization,
organizational-level factors influencing implementation, and exploration of the
costs associated with care planning. Comparative studies using rigorous and
appropriate measures and design approaches are needed to better understand if and
how care planning interventions may affect survivors' morbidity, utilization of
health care, adherence to healthy behavior and surveillance guidelines, health
care utilization, and related costs.

Specific Research Objectives

Applications are expected to
assess whether care planning renders added benefits in terms of
morbidity, adherence to follow-up guidelines and self-management of late
effects, appropriate utilization of follow-up care, and cost, and if so, seek to
describe the pathways and processes through which such benefit is derived and
for which stakeholders (survivors, clinicians, delivery systems, payors).
Transdisciplinary approaches that link health services and health economics
research with clinical, behavioral, and social science disciplines are encouraged.
Studies documenting the organizational context and key processes through which
successful care planning occurs are invited, including those that study how the
generation and use of survivorship care plans intersects with processes of care
delivery, inter-provider communication, patient-provider communication, and
meaningful use of informatics. Studies linking care planning to use of
electronic medical records, and exploring ways to harness electronic platforms,
tools and applications are encouraged. Studies of how successful care planning
initiatives are implemented in a variety of healthcare and community practice
settings are encouraged. Studies may include family and caregiver outcomes in
addition to survivor outcomes.

Inclusions:

Research applications are expected to include at least one
survivor-level outcome (behavioral, physical and/or psychosocial morbidity) and
at least one provider or system-level outcome related to care delivery or cost.

Studies assessing the impact of care planning or identifying
effective models of care are expected to use comparative designs (randomized
controlled trials, quasi-experimental, case-control, interrupted time series,
or similar designs) that allow comparison of care planning strategies to
“usual” care.

Adjunctive qualitative or quantitative observational approaches
are encouraged in the context of the above designs.

Because the standard of care is not yet consistently established,
investigators are expected to carefully document and describe the care planning
protocol studied in all inquiries. Studies are encouraged to use care plans
that include, but are not limited to, Institute of Medicine-recommended content
for survivorship care plans.

Eligible studies are restricted to those that focus on individuals
diagnosed with cancer at age 21 or older.

Studies focused on the development and testing of instruments to
evaluate survivorship care planning may use the R01 mechanism or the companion
R21 mechanism, as appropriate.

Research
areas of interest include, but are not limited, to:

What are the best constructs and outcomes for evaluating
survivorship care planning and which metrics are best suited to measure these?

What is the impact of survivorship care planning on cancer
survivors’ post-treatment psychosocial and physiologic morbidity?

What is the effect of survivorship care planning on adherence to
screening recommendations, preventive behaviors, and self-management of late
and long-term effects of cancer?

What is the optimal timing for delivery of survivorship care
planning?

What are the differential costs associated with the generation
and implementation of care plans versus usual care, and what value is added, if
any?

Who should be involved, and how, in the development and delivery
of care plans? What are the respective roles of oncology and primary care
physicians, nurses, social workers, and other allied health professionals in
the care planning process?

What systems, organizational and provider-level factors influence
the generation, transmission, communication, usability, and ultimate consistent
use of survivorship care plans?

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal
Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications
from the SF 424 (R&R) Application Guide.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Foreign Institutions

Foreign (non-US) institutions must follow policies described
in the NIH
Grants Policy Statement, and procedures for foreign institutions described
throughout the SF424 (R&R) Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF 424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the following review criteria and additional review criteria
(as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD(s)/PI(s), do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign
Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.